Article preview reprinted from IN VIVO - December/January 2010
EBI's Medical Device Team
When we first discussed appending a "Top Stories of the Decade" to our annual Top Ten feature, the reaction was mixed. On the one hand, we thought most readers could probably recite them off the top of their heads as easily as we could. But when we began to compile the list, a few things jumped out, well worth reiterating: the prolonged back and forth of the debate over drug-eluting stents (DES), in some ways a first look at how a comparative effectiveness research mindset can move clinicians, but not necessarily in a uniform direction over time; the strength and distinctiveness of orthopedics dealmaking; the emergence of areas such as opththalmology and aesthetics; and the steady turn towards financing devices as an alternative to pharma, with its own distinctive characteristics and arguments in their favor. Read more...
Top Device Stories of the Decade
Article preview reprinted from IN VIVO - December/January 2010
EBI's Medical Device Team
When we first discussed appending a "Top Stories of the Decade" to our annual Top Ten feature, the reaction was mixed. On the one hand, we thought most readers could probably recite them off the top of their heads as easily as we could. But when we began to compile the list, a few things jumped out, well worth reiterating: the prolonged back and forth of the debate over drug-eluting stents (DES), in some ways a first look at how a comparative effectiveness research mindset can move clinicians, but not necessarily in a uniform direction over time; the strength and distinctiveness of orthopedics dealmaking; the emergence of areas such as opththalmology and aesthetics; and the steady turn towards financing devices as an alternative to pharma, with its own distinctive characteristics and arguments in their favor.
2000
IPO Window Opens; Then Closes. Device investors initially were encouraged by the IPOs for Aspect Medical Systems Inc. (now part of Covidien Ltd.) and Oratec Interventions Inc. (since acquired by Smith & Nephew PLC), among others, leading some to hope the market for device companies would be opening for the first time since 1996. Shares in these companies quickly lost value, however, sending the device industry into a three-year tailspin.
The Prodigal Stent-Maker Returns. The year 2000 was an amazing one for Johnson & Johnson's Cordis Corp. Having created the market and captured a 90%+ share in the mid-1990s for the tiny slotted metal tubes called stents that many industry experts thought would only be a niche product, J&J had found itself quickly overtaken in the next few years as competitors out-innovated the innovator with subsequent generations of stents, reducing it to single-digit market share. But reports of J&J's demise from the stent market proved to be quite premature as new product introductions in 2000 boosted the company's market share. A big win in patent litigation would not only result in a large cash award but also would severely disadvantage competitors.
2001The Triumph of Drug-Eluting Stents. The long-discussed potential of drug-coated stents finally got its proof in 2001. And what proof it was: data from the RAVEL trial of Cordis' sirolimus-coated stents surpassed the dreams of even the most optimistic executives at the Johnson & Johnson unit—0% restenosis. The drug/device combination thus potentially solved one of the most intractable problems in interventional cardiology and challenged competitive approaches, both pharmacological (for example, investors quickly downgraded market assumptions for IIb/IIIa inhibitors) as well as a whole generation of device companies that were working on alternative approaches for treating restenosis, like radiation therapy.
The Orthopedics Boom. Not long before, the slow-growth orthopedics business had attracted little investor attention, despite favorable demographics, huge profits, and large markets. But in 2001, orthopedics was one of the only bright spots in the generally dismal device investment field as investors, in part driven by the decline of tech stocks, apparently gained new appreciation for safe and steady havens such as orthopedics. Zimmer Holdings Inc. and Wright Medical Group Inc. pulled off successful IPOs while industry stalwarts Biomet Inc. and Stryker Corp. continued to see stock prices rise.
2002Orthopedics Goes Soft. Not the market itself, which had another robust year in pricing and profitability, but the approval that summer of Medtronic Inc. division Medtronic Sofamor Danek's Infuse, the bone morphogenetic protein. To the long-asked question: will biologics reshape therapeutic choices in a discipline where hardware has long been the surgeon's preferred option, the market—at least the spine market—enthusiastically responded, "Yes." Infuse's promise heralded larger changes for an orthopedics industry flush with success, much as drug-eluting stents (DES) had done for cardiovascular devices.
Vulnerable Plaque Moves Center Stage. In any other year, the fact that DES were approved for sale would have been the big news in cardiovascular devices. But many companies were already looking at the next big thing: devices to diagnose and treat vulnerable plaque, which, like the stents, brought biologics to bear on traditional devices. And vulnerable plaque challenged device companies, well equipped to deal with mechanical problems but maybe overmatched when it came to solving biological problems, particularly if vulnerable plaque proved to be a systemic condition.
2003The Battle Begins in DES. Thus far in the decade, the biggest story in medical devices had been the advent of DES and their primary beneficiary: Johnson & Johnson. No longer: Boston Scientific Corp. (BSC) arrived on the DES market, with extremely good results from its Taxus trials. Guidant Corp. and Medtronic were still several years away at least from joining the fray, but J&J wasn't taking the competition lightly. Its REALITY trial would be the first head-to-head comparison of its and BSC's stents. For J&J, the challenge was not to repeat the missteps it made in bare-metal stents, when it lost 90% of a business it had virtually owned to fast followers. In other words, it was time to stop dreaming and start marketing.
Companies mentioned in this article:
Abbott Laboratories Inc.
Allergan Inc.
Inamed Corp.
Bausch & Lomb Inc.
Beckman Coulter Inc.
Biomet Inc.
Boston Scientific Corp.
CryoCor Inc.
Bristol-Myers Squibb Co.
Concentric Medical Inc.
Cook Group Inc.
Covidien Ltd.
Aspect Medical Systems Inc.
DJO Inc.
Edwards Lifesciences Corp.
GI Dynamics Inc.
General Electric Co.
GlaxoSmithKline PLC
Stiefel Laboratories Inc.
Inverness Medical Innovations Inc.
Johnson & Johnson
Biosense Webster Inc.
Cordis Corp.
DePuy Spine Inc.
Ethicon Inc.
Mentor Corp.
Lantheus Medical Imaging Inc.
Medicis Pharmaceutical Corp.
Medtronic Inc.
Kyphon Inc.
Medtronic CryoCath LP
Medtronic Sofamor Danek
National Institutes of Health
OSI Pharmaceuticals Inc.
OSI Eyetech
Olympus Corp.
Gyrus Group PLC
Gyrus Medical Inc.
Optobionics Corp.
Siemens AG
Smith & Nephew PLC
St. Jude Medical Inc.
Stryker Corp.
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